Fluorescence Imaging in Sentinel Lymph Node Biopsy for Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.

Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure.

The patient will then be taken to the operating room, without deviating from normal operating procedures for this surgical procedure. Prior to starting the operation, the patient will undergo injection of ICG around the tumor per standard techniques while in the operating room

Patients will then undergo the standard SLN biopsy procedure.

After gamma probe and methylene blue identification of the SLN as per standard of care, the surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance. After this is performed, the goggle system will be removed and the SLN biopsy will be completed per standard techniques. Lymph nodes that are fluorescent from ICG detected with the goggles will also be removed if the node identified in the dissected nodal basin. All three visualizations will be performed prior to removal and the nodes will then be sent for pathologic confirmation of node positivity or negativity.

Drug: IC-GREEN

-Injection of ICG around the tumor per standard techniques will in the operating room and 0.5-2.5 mL of 500 micromolar ICG will be injected peri-tumorly into the subcutaneous tissue of the surrounding skin.

Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]

-Feasibility will be assessed in terms of percentage of patients enrolled for whom peri-tumoral injection with ICG is performed successfully

Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]

-Feasibility will be assessed in terms of percentage patients whom the sentinel and superficial lymph nodes will be detected from the hands free goggle device

Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]

-Feasibility will be assessed in terms of percentage of total lesions identified from the new technique are truly positive as confirmed by biopsy

Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure [ Time Frame: Up to 1 week after surgery ]

-Feasibility will be assessed in terms of the the percentage of total positive SNLs being missed from the new device

Secondary Outcome Measures :

Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device [ Time Frame: Up to 1 week after surgery ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adults aged 18 years or older will be considered eligible.

Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma, that are candidates for sentinel lymph node biopsy.